ShuntCheckT is the first device to allow quick, non-invasive detection of cerebrospinal fluid (CSF) flow through shunts. Using a system based on transcutaneous thermal convection technology, ShuntCheckT can be used to painlessly evaluate the function of a shunt quickly and accurately in an office, Emergency Room, or any ambulatory setting. This simple procedure involves placing an ice cube over the shunt. A single use, disposable temperature sensor is placed on the skin over the shunt tubing. As the CSF flows past the area where the ice is applied, the fluid cools. The temperature sensor detects this change in temperature and transmits the data to the handheld ShuntCheckT BioDisplay device. The time and temperature readings are analyzed by ShuntCheck's software and generate a "Flow Confirmed" or "Flow Not Confirmed".

ShuntCheckT is an aid to the detection of flow in implanted silastic cerebrospinal fluid (CSF) shunts. ShuntCheckT cannot alone diagnose CSF shunt function or malfunction. The clinical diagnosis of CSF shunt function or malfunction, incorporating the flow information from ShuntCheckT, should be made only by a qualified neurosurgeon.

There are approximately 300,000 shunted hydrocephalus patients in the US. Hydrocephalus prevalence and use of shunts for treatment are similar in Europe and Japan. Each year, US neurosurgeons perform 41,000 shunt procedures - 12,0002 new procedures and 29,0002 revisions - and conduct periodic exams on their existing shunted patients. ShuntCheckT will be used to test symptomatic patients in the ER and asymptomatic patients in the neurosurgical office:

Patients exhibiting the symptoms of shunt malfunction (headache, nausea, lethargy) present at Emergency Rooms and at Neurosurgeon offices for emergency testing. A study at the Children's Hospital of Philadelphia (CHOP) indicates that they see three false alarms for every true shunt malfunction. ShuntCheckT will be a very useful initial test for on these patients.

Neurosurgeons conduct post-surgical follow up exams on recently shunted patients and they see their existing patients one to two times per year. ShuntCheckT testing can provide useful periodic monitoring for these patients.

Results from NeuroDx testing submitted to the FDA (using an animal model of shunt flow), show that ShuntCheck's diagnostic accuracy compares favorably to the existing, more expensive and invasive diagnostic procedures.

Diagnostic
Procedures

Sensitivity(Accuracy in detecting No Flow)

Specificity(Accuracy in detecting Flow)

CT Scan

68%

90%

Shunt Tap

79%

56%

Radio Isotope

80%

53%

Xray Series

27%

99%

ShuntCheck Study
submitted to the FDA

100% (N=80)

92% (N=80)

The strong sensitivity performance is particularly important because it means that ShuntCheck is an extremely accurate "rule out" test - and will be very useful in ruling out shunt failure in symptomatic patients. That suggests that ShuntCheck will become the first test for these patients.